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Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Drug Discovery: Overview

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Post-Approval Research in Drug Development: Priorities and Practices.

David Williamson¹, Jack Sheehan², Ella Daly³

¹University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Mobile, AL, USA.

Advances in Neurobiology

|March 17, 2023

Summary

Post-approval studies are crucial for understanding new medication benefits beyond initial trials. These studies help clinicians and payers assess real-world effectiveness, safety, and cost for diverse patient groups.

Keywords:

Phase 4 trials Post-approval research

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Last Updated: Aug 6, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Published on: February 19, 2021

Area of Science:

Pharmacoeconomics
Clinical Research
Health Services Research

Background:

Clinical trials for initial drug approval often use narrow patient criteria, limiting generalizability.
Prescribers and payers require real-world data to assess medication value for specific patient populations.
Understanding a drug's post-market performance is essential for informed clinical and economic decisions.

Approach:

This chapter reviews research questions pertinent to post-regulatory approval drug evaluation.
It outlines common methodologies employed in post-market drug studies.
It discusses resource allocation criteria for prioritizing such investigations.

Key Points:

Post-approval studies address real-world effectiveness, safety, tolerability, and affordability.
Stakeholders like regulators, patients, and clinicians benefit from this expanded data.
Methodologies vary, necessitating careful consideration for study design.

Conclusions:

Continued examination of medications after regulatory approval is vital.
Real-world evidence complements initial trial data for comprehensive drug assessment.
Prioritizing post-market research ensures optimal resource allocation and patient care.